Pulmonary HypertensionNCT05958901
Pulmonary Hypertension Observational Study
An observational study of Pulmonary Hypertension, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to establish the large PH cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- pulmonary hypertension
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2023to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a observational prospective longitudinal cohort study to to establish the large PH cohort and biological database in China, including PH subjects( n= 5000) and healthy subjects (n= 5000). Sites Investigators will be respiratory physicians working in the respiratory department of our sites, which must be tier 2 or tier 3 hospitals in China, with the equipment and ability to conduct right heart catheterization(RHC). Patients must meet all the inclusion criteria and none of the exclusion criteria. No additional investigational drugs will be applied to the patients. Statistical analysis will be conducted by epidemiology \& statistics work group from Chinese Academy of Sciences, using SAS and R software. Paper-based questionnaire administration will also be used. Questionnaire variables will be checked before data entry. During the study, PI will be in charge of the monitoring of the whole procedure.
Who may be able to join
- PH group: When the mean pulmonary artery pressure is greater than 25mmHg at rest or greater than 30mmHg during exercise.
- Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years.
Who cannot join
- Acute exacerbation in the past 3 months Having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc.
- Serious uncontrolled diseases thoracic or abdominal surgery in the last 3 months.
- Eye surgery in the last three months.
- Retinal detachment myocardial infarction in the last 3 months.
- Admission to hospital for any cardiac condition in the last month.
- Heart rate over 120 beats per minute.
- Antibacterial chemotherapy for tuberculosis pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Zili Zhang, PHD, 18922269968, zhangzili_04@163.com
About this study
Official title: A Observational Study in Chinese Patients With Pulmonary Hypertension (PH)
The purpose of this study is to establish the large PH cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices.
- Conditions
- Pulmonary Hypertension
- Being tested
- pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary hypertensionOther
The final outcome observed was a diagnosis of pulmonary hypertension.
| Study group | Role | What they receive |
|---|---|---|
| pulmonary hypertension | Not described Receives: Other: pulmonary hypertension | |
| healthy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean pulmonary arterial pressure
For an adult at sea level, when the mean pulmonary arterial pressure is greater than 25 mmHg at rest or greater than 30mmHg during exercise.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start12 Jul 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zili zhang, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958901
- Sponsor's protocol ID
- Pulmonary Hypertension of GIRH
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Observational Study in Chinese Patients With Pulmonary Hypertension (PH)
- ClinicalTrials.gov ID
- NCT05958901
- Acronym / sponsor ID
- Pulmonary Hypertension of GIRH
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the large PH cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulmonary hypertension | – | Other: pulmonary hypertension |
| healthy | – | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a observational prospective longitudinal cohort study to to establish the large PH cohort and biological database in China, including PH subjects( n= 5000) and healthy subjects (n= 5000). Sites Investigators will be respiratory physicians working in the respiratory department of our sites, which must be tier 2 or tier 3 hospitals in China, with the equipment and ability to conduct right heart catheterization(RHC). Patients must meet all the inclusion criteria and none of the exclusion criteria. No additional investigational drugs will be applied to the patients. Statistical analysis will be conducted by epidemiology \& statistics work group from Chinese Academy of Sciences, using SAS and R software. Paper-based questionnaire administration will also be used. Questionnaire variables will be checked before data entry. During the study, PI will be in charge of the monitoring of the whole procedure.
Key inclusion criteria (2 listed)
- PH group: When the mean pulmonary artery pressure is greater than 25mmHg at rest or greater than 30mmHg during exercise.
- Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years.
Key exclusion criteria (7 listed)
- Acute exacerbation in the past 3 months Having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc.
- Serious uncontrolled diseases thoracic or abdominal surgery in the last 3 months.
- Eye surgery in the last three months.
- Retinal detachment myocardial infarction in the last 3 months.
- Admission to hospital for any cardiac condition in the last month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary hypertensionThe final outcome observed was a diagnosis of pulmonary hypertension. | Other | pulmonary hypertension |
Primary outcome
mean pulmonary arterial pressure
Time frame: 12 months
For an adult at sea level, when the mean pulmonary arterial pressure is greater than 25 mmHg at rest or greater than 30mmHg during exercise.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean pulmonary arterial pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.